Intensive Care Unit
Conditions
Interventions
Sponsors
Erasmus MC
Eligibility
Inclusion criteria
Inclusion criteria: - Patient is hemodynamically stable and communicable (RASS of -2 or higher in the 24h before intended inclusion: meaning patient is at least briefly awakened with eye contact to voice). - Expected ICU stay upon randomisation of at least another 48 hours. - Written informed consent acquired from the patient or legal representative.
Exclusion criteria
Exclusion criteria: - Patients with severe hearing impairment, defined as no verbal communication possible. - Neurological condition (e.g. severe stroke), when deemed to interfere with processing of music (e.g. not applicable to patients with minor stroke in past medical history without significant residual neurological deficits; those patients could be included). - Insufficient knowledge of the Dutch or English language for informed consent. - Participation in another study that may possibly intervene with the primary outcome measure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anxiety measured using the Visual Analogue Scale for Anxiety (VAS-A) questionnaire immediately after each music session during three consecutive days after inclusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Anxiety: measured using the 6-item short version State -Trait Anxiety Inventory (STAI-6) questionnaire immediately after each music session during three consecutive days after inclusion. - Agitation and sedation level: measured using the Richmond Agitations- Sedation Scale (RASS), assessed three times daily during every shift, as long as the patient is mechanically ventilated and/or sedated as part of the standard care procedure. - Medication requirement (duration and dosages, corrected for body weight milligram/killogram), including remifenanyl, propofol, benzodiazepines, dexmedetomidine, clonidin, paracetamol, sufentanyl, fentanyl, morphine, ketamine, epidural analgesia, haloperidol, and other benzodiazepines, atypical anxiolytics and antipsychotics. - Pain: measured using the Critical Pain Observation Tool (CPOT) in mechanically ventilated patients, or the NRS/VAS for pain in non-ventilated and alert/oriented as part of the standard care procedure. - Sleep quality: assessed daily in the morning after awakening, starting before the music session at baseline, and during the intervention period. Sleep will be assessed using a visual numeric scale ranging from one to seven, in which one indicates “did not/barely sleep” and seven indicates: “slept very well” - Delirium: measured with the Intensive Care Delirium Screening Checklist (ICDSC), which is routinely done in all ICU patients, three times daily, as part of the standard care procedure. - ICU memory and experience: assessed by the ICU memory tool (ICU-MT) extended with self-made questions to assess ICU experience, once at the end of the study period. - Complications related to agitation: defined as removal of lines and tube (auto-detubation) by the patient. - Time spend on mechanical ventilation: measured in total amount of hours. - ICU length of stay (LOS): measured in total amount of hours spend in the ICU after inclusion. - Physical parameters: daily heart rate (HR), and arterial bl | — |
Contacts
Public ContactEllaha Kakar
Erasmus Medical Centre
Outcome results
None listed